A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

OBJECTIVES: I. Collect human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma diagnosed and/or treated at a Children's Oncology Group (COG) member institution. II. Provide a repository for storage of tissue and other biological specimens collected by COG investigators from these patients. III. Make these specimens available for approved projects by laboratory-based investigators. IV. Collect clinical data on these patients who are not being treated on a COG therapeutic study. V. Define and compare the clinical features of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry the t(2;13), t(1;13) or neither translocation. VI. Investigate the relationship between evidence of submicroscopic disease and response rate (CR/PR), failure-free survival, and survival of patients with alveolar rhabdomyosarcoma, as determined by positive or negative reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the t(2:13) and t(1:13) on peripheral blood and bone marrow specimens obtained at diagnosis. VII. Compare the clinical, cytogenetic, and molecular biologic features of patient subgroups with anaplastic rhabdomyosarcoma and other subtypes of rhabdomyosarcoma. OUTLINE: Surgical tissue, bone marrow, and blood specimens are collected at diagnosis (initial or relapse) and, if applicable, at the development of a second primary tumor. Specimens are used for research purposes. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute. Patients who are not enrolled on a Children's Oncology Group treatment trial are followed every 6 months for at least 10 years or until disease progression or development of a second malignancy.

Who is eligible to participate?

Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of 1 of the following: - Rhabdomyosarcoma - Non-rhabdomyosarcoma soft tissue sarcoma - Chordoma - Desmoid fibromatosis - Desmoplastic round cell tumors - Undifferentiated embryonal sarcoma of the liver - Unclassified soft tissue sarcoma that is too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS") - Other soft tissue neoplasms, excluding benign tumors - Must have pathological specimens of tumor-containing tissue or bone marrow (beyond that needed by the institution for diagnosis) available for study - No malignant rhabdoid tumor, Ewing sarcoma/primitive neuroectodermal tumor, or osteogenic sarcoma of bone - No osteogenic sarcoma

Last updated:

2/12/2014

NCT ID:

NCT00919269

IRB Number:

990-99